Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00133744
Status:
COMPLETED
Last Update Posted:
2011-03-21
First Post:
2005-08-22
Brief Title:
Impact of Prenatal VitaminMineral Supplements on Perinatal Mortality
Sponsor:
Centers for Disease Control and Prevention
Organization:
Centers for Disease Control and Prevention
Study Overview
Official Title:
Impact of IronFolic Acid Versus Multimicronutrient Versus Folic Acid Supplements During Pregnancy on Mortality Morbidity and Complications During Pregnancy Labor and Delivery A Randomized Controlled Trial in China
Status:
COMPLETED
Status Verified Date:
2011-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether a daily prenatal supplement of iron plus folic acid or a daily prenatal supplement with multiple vitamins and minerals given to women from their first prenatal visit through delivery reduces perinatal mortality compared with a daily prenatal supplement of folic acid alone
Detailed Description:
In the project area in China the rate of perinatal mortality stillbirths and infant deaths within 6 days of birth is two times that of the United States Causes of perinatal mortality include but are not limited to low birth weight and preterm delivery Anemia low hemoglobin among pregnant women is associated with low birth weight and preterm delivery and also is elevated in the project area Supplements of iron folic acid and other vitamins and minerals can prevent anemia among pregnant women but the effects of these supplements on other maternal and infant health outcomes are unclear
Since 1993 the Peoples Republic of China has recommended that newly married women and those who plan pregnancy take 400μg of folic acid daily through the first trimester of pregnancy Although WHO recommends that pregnant women take iron and folic acid supplements there is currently no national recommendation that pregnant women in China take iron or other vitamin or mineral supplements other than folic acid UNICEF is now testing a prenatal vitamin and mineral supplement in programs to prevent low birth weight Our study will provide additional information about the health impact of the UNICEF prenatal supplement versus an iron and folic acid supplement versus folic acid alone
Comparisons
Infants of women who receive daily prenatal supplements that contain 400μg folic acid alone will be compared with infants of women who receive daily supplements that contain 30 mg iron and 400 μg folic acid
Infants of women who receive daily supplements that contain 30 mg iron and 400 μg folic acid will be compared with infants of women who receive a daily supplement containing 30 mg iron 400μg folic acid and other vitamins and minerals UNICEF formulation
Since 1993 the Peoples Republic of China has recommended that newly married women and those who plan pregnancy take 400μg of folic acid daily through the first trimester of pregnancy Although WHO recommends that pregnant women take iron and folic acid supplements there is currently no national recommendation that pregnant women in China take iron or other vitamin or mineral supplements other than folic acid UNICEF is now testing a prenatal vitamin and mineral supplement in programs to prevent low birth weight Our study will provide additional information about the health impact of the UNICEF prenatal supplement versus an iron and folic acid supplement versus folic acid alone
Comparisons
Infants of women who receive daily prenatal supplements that contain 400μg folic acid alone will be compared with infants of women who receive daily supplements that contain 30 mg iron and 400 μg folic acid
Infants of women who receive daily supplements that contain 30 mg iron and 400 μg folic acid will be compared with infants of women who receive a daily supplement containing 30 mg iron 400μg folic acid and other vitamins and minerals UNICEF formulation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None